Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001500741p
Ethics application status
Submitted, not yet approved
Date submitted
12/10/2022
Date registered
30/11/2022
Date last updated
30/11/2022
Date data sharing statement initially provided
30/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of mobile phone TEXT messages to increase the adherence of SGLT2 Inhibitors: a MULti-country Effectiveness-Implementation trial (TEXT-STIMULI)
Scientific title
Use of mobile phone TEXT messages to increase the adherence of SGLT2 Inhibitors: a MULti-country Effectiveness-Implementation trial (TEXT-STIMULI)
Secondary ID [1] 308010 0
CTC 0374
Universal Trial Number (UTN)
Trial acronym
TEXT-STIMULI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adherence to medication use of sodium–glucose co-transporter-2 (SGLT2) inhibitors. 327681 0
Condition category
Condition code
Renal and Urogenital 324766 324766 0 0
Kidney disease
Cardiovascular 324767 324767 0 0
Coronary heart disease
Metabolic and Endocrine 324768 324768 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is mobile phone text messages received by participants in addition to standard of care for 12 months. Participants randomised to the intervention group will receive regular mobile phone text messages containing educational and motivational content and/or medication adherence reminders. These may include delivery of infographic factsheets or animated videos which have been developed for the purposes of this study or published online factsheets by The Baker Heart and Diabetes Institute, an independent Australian-based research institute producing evidence-based resources by experts, for use by clients and health professionals for patient education

At week 4, participants within the intervention group will be randomised (1:1) to receive a set program (TEXT-S) of 3 messages per week, or a personalised program (TEXT-P), which will allow participants to choose a text message frequency ranging from 2 to 4 messages per week.

The text-messages will be delivered automatically via the TEXTCARE platform. The delivery of text messages will not be monitored via the platform, however, checks by the central study coordinator to ensure participants are receiving the text messages as designed may be incorporated. All responses from participants to any automatic messages received by the TEXTCARE platform will be monitored.
Intervention code [1] 324462 0
Behaviour
Comparator / control treatment
Participants randomised to control group will receive an introductory text message and then will not receive regular mobile phone text messages in addition to standard of care. Standard of Care is the care and instruction that participants would normally receive from their healthcare provider if they weren’t participating in this study. For patients who are newly prescribed an SGLT2i, this may include some background and instructions from their prescribing doctor or nurse about the reasons, importance and/or side effects of the medication. There will be no separate ‘Standard of Care’ for each health care provider.
Control group
Active

Outcomes
Primary outcome [1] 332589 0
The proportion of days covered by an SGLT2 inhibitor at 12 months, according to Pharmaceutical Benefits Scheme (PBS) and PharmaNet prescription data.
Timepoint [1] 332589 0
12 months post-randomisation
Primary outcome [2] 332590 0
Self-reported adherence to SGLT2i medication in the previous 30 days at 12 months.
Timepoint [2] 332590 0
12 months post-randomisation
Secondary outcome [1] 413995 0
The proportion of days covered by an SGLT2 inhibitor at 6 and 18 months, according to PBS and PharmaNet prescription data.
Timepoint [1] 413995 0
6 and 18 months post-randomisation
Secondary outcome [2] 413996 0
Full adherence at six months (defined as 80% or more of days covered by an SGLT2 inhibitor) according to PBS and PharmaNet prescription data.
Timepoint [2] 413996 0
6 months post-randomisation
Secondary outcome [3] 413997 0
Full adherence at twelve months (defined as 80% or more of days covered by an SGLT2 inhibitor) according to PBS and PharmaNet prescription data.
Timepoint [3] 413997 0
12 months post-randomisation
Secondary outcome [4] 413998 0
Self-reported medication adherence at 6 months.
Timepoint [4] 413998 0
6 months post-randomisation
Secondary outcome [5] 413999 0
Rates of primary non-adherence to SGLT2i medications as defined as participants who have never filled a prescription according to PBS prescription data
Timepoint [5] 413999 0
6, 12 and 18 months post-randomisation
Secondary outcome [6] 414000 0
Adherence rate at 18 months according to PBS/PharmaNet prescription data, 6 months post intervention cessation.
Timepoint [6] 414000 0
18 months post-randomisation
Secondary outcome [7] 414001 0
The usefulness, feasibility and user-experience of the intervention.

This is a composite secondary outcome. Semi structured one-on-one interviews and/or focus groups will be conducted to describe participants' experience including feasibility, usefulness and engagement with the intervention. Using principles of grounded theory, thematic analyses and inductive reasoning similar concepts and themes will be grouped together. Interviews or focus groups will be conducted in-person or on the telephone within eight weeks of completing the intervention and are expected to take between 30-60 minutes. The interviews and focus groups will be conducted by a member of the investigative team.
Timepoint [7] 414001 0
12 months post-randomisation

Eligibility
Key inclusion criteria
An indication for SGLT2 Inhibitor (as per Australian and Canadian guidelines at time of assessment).
Receiving a first, and ongoing, prescription for an SGLT2 Inhibitor.
Access to an operational smart mobile telephone that can send and receive text messages, open multimedia files, and access the Internet.
Sufficient English language proficiency to read and understand text messages on a mobile telephone.
Willing and able to perform trial related procedures.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Life expectancy less than 12 months.
Already prescribed an SGLT2i more than 3 months prior to assessment.
Diagnosed with Type 1 diabetes mellitus or gestational diabetes.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The method of generating the allocation sequence is computer generated random numbers. The randomisation will be stratified by country.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/12/2022
Actual
Date of last participant enrolment
Anticipated
30/12/2023
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
476
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment outside Australia
Country [1] 25017 0
Canada
State/province [1] 25017 0

Funding & Sponsors
Funding source category [1] 312273 0
University
Name [1] 312273 0
The University of Sydney
Country [1] 312273 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Medical Foundation Building
L5, 92-94 Parramatta Road,
Camperdown, 2050, NSW
Australia
Country
Australia
Secondary sponsor category [1] 313817 0
None
Name [1] 313817 0
Address [1] 313817 0
Country [1] 313817 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311646 0
Western Sydney Local Health District Ethics Committee
Ethics committee address [1] 311646 0
5 Fleet St, North Parramatta NSW 2151
Ethics committee country [1] 311646 0
Australia
Date submitted for ethics approval [1] 311646 0
20/10/2022
Approval date [1] 311646 0
Ethics approval number [1] 311646 0

Summary
Brief summary
The medications known as sodium-glucose co-transporter-2 inhibitors (SGLT2i) provide major benefits to important patient outcomes including a reduced likelihood of cardiovascular events or hospitalisations for heart failure, and a reduced risk of advanced kidney disease or kidney failure, in addition to helping to prevent or manage diabetes, to lower blood pressure, and to facilitate weight loss. Despite their many benefits, at least a third of people discontinue taking these agents within 12 months. Stakeholder engagement and external research suggests that improving patient education about the many benefits of the agents, teaching strategies to prevent side effects and providing advice about ways to remember to take medications consistently could significantly boost adherence. Text messaging provides an innovative way to deliver education and support using ubiquitous technology, and text message interventions have been used to significantly improve adherence for people with other chronic diseases. The TEXT-STIMULI trial is a randomised control trial which investigates the effectiveness of a text messaging program to improve adherence to SGLT2i, while simultaneously assessing the feasibility of implementing the intervention on a wider scale.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121838 0
Prof Meg Jardine
Address 121838 0
The NHMRC Clinical Trial Centre
Medical Foundation Building
Level 6, 92-94 Parramatta Road,
Camperdown, 2050, NSW
Australia
Country 121838 0
Australia
Phone 121838 0
+61 2 9562 5005
Fax 121838 0
Email 121838 0
[email protected]
Contact person for public queries
Name 121839 0
Ms Erika Dempsey
Address 121839 0
The NHMRC Clinical Trial Centre
Medical Foundation Building
Level 6, 92-94 Parramatta Road,
Camperdown, 2050, NSW
Australia
Country 121839 0
Australia
Phone 121839 0
+61 2 7906 5613
Fax 121839 0
Email 121839 0
[email protected]
Contact person for scientific queries
Name 121840 0
Ms Erika Dempsey
Address 121840 0
The NHMRC Clinical Trial Centre
Medical Foundation Building
Level 6, 92-94 Parramatta Road,
Camperdown, 2050, NSW
Australia
Country 121840 0
Australia
Phone 121840 0
+61 2 7906 5613
Fax 121840 0
Email 121840 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.